NCT07464327

A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations

A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Hansoh BioMedical R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.

Detailed description

This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations. Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093 and adebrelimab) or the control arm (docetaxel injection). Participants in the experimental arm will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met. Participants in the control arm will receive docetaxel at a dose of 75 mg/m² Q3W until disease progression or other treatment discontinuation criteria are met. Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedures.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HS-20093	Participants will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met.
DRUG	Docetaxel	Participants will receive docetaxel at a dose of 75 mg/m² Q3W until disease progression or other treatment discontinuation criteria are met.

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-03-11
• Last updated: 2026-03-11